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NITAZOXANIDE SUPERIORITY TO PLACEBO TO TREAT MODERATE COVID-19 A PILOT PROVE OF CONCEPT RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL
Nitazoxanide
Ensaio clínico controlado randomizado
Marcadores de ativação celular linfócitos
Interleucinas
Nitazoxanide
Randomized controlled clinical trial
Lymphocytes cell activation markers
Interleukins
Autor
Blum, Vinicius Fontanesi
Cimerman, Sérgio
Hunter, James R.
Tierno, Paulo
Lacerda, Acioly
Soeiro, Alexandre
Cardoso, Florentino
Bellei, Nancy Cristina
Maricato, Juliana
Mantovani, Nathalia
Vassao, Marcela
Dias, Danilo
Gallinskas, Juliana
Janini, Luis Mario Ramos
Oliveira, Joanna Reis Santos
Cruz, Alda Maria da
Diaz, Ricardo Sobhie
Cimerman, Sérgio
Hunter, James R.
Tierno, Paulo
Lacerda, Acioly
Soeiro, Alexandre
Cardoso, Florentino
Bellei, Nancy Cristina
Maricato, Juliana
Mantovani, Nathalia
Vassao, Marcela
Dias, Danilo
Gallinskas, Juliana
Janini, Luis Mario Ramos
Oliveira, Joanna Reis Santos
Cruz, Alda Maria da
Diaz, Ricardo Sobhie
Afiliación
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Instituto de Infectologia Emilio Ribas. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Hospital Municipal Dr. Francisco Moran (Barueri). Guarulhos, SP, Brasil.
SPDM (Guarulhos). Sao Paulo, SP, Brasil
INCOR and Beneficiência Portuguesa. São Paulo, SP, Brasil.
Hospital Vera Cruz. Campinas, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Interdisciplinar de Pesquisa Médicas. Rio de Janeiro, RJ, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Instituto de Infectologia Emilio Ribas. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Hospital Municipal Dr. Francisco Moran (Barueri). Guarulhos, SP, Brasil.
SPDM (Guarulhos). Sao Paulo, SP, Brasil
INCOR and Beneficiência Portuguesa. São Paulo, SP, Brasil.
Hospital Vera Cruz. Campinas, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Interdisciplinar de Pesquisa Médicas. Rio de Janeiro, RJ, Brasil.
Universidade Federal de São Paulo. São Paulo, SP, Brasil.
Resumen en ingles
Background: The absence of specific antivirals to treat COVID-19 leads to the repositioning of candidates’
drugs. Nitazoxanide (NTZ) has a broad antiviral effect.
Methods: This was a randomized, double-blind pilot clinical trial comparing NTZ 600 mg BID versus Placebo
for seven days among 50 individuals (25 each arm) with SARS-COV-2 RT-PCR+ (PCR) that were hospitalized
with mild respiratory insufficiency from May 20th, 2020, to September 21st, 2020 (ClinicalTrials.gov
NCT04348409). Clinical and virologic endpoints and inflammatory biomarkers were evaluated. A five-point
scale for disease severity (SSD) was used.
Findings: Two patients died in the NTZ arm compared to 6 in the placebo arm (p = 0.564). NTZ was superior to
placebo when considering SSD (p < 0001), the mean time for hospital discharge (6.6 vs. 14 days, p = 0.021),
and negative PCR at day 21 (p = 0.035), whereas the placebo group presented more adverse events (p = 0.04).
Among adverse events likely related to the study drug, 14 were detected in the NTZ group and 22 in placebo
(p = 0.24). Among the 30 adverse events unlikely related, 21 occurred in the placebo group (p = 0.04). A
decrease from baseline was higher in the NTZ group for D-Dimer (p = 0.001), US-RCP (p < 0.002), TNF
(p < 0.038), IL-6 (p < 0.001), IL-8 (p = 0.014), HLA DR. on CD4+ T lymphocytes (p < 0.05), CD38 in CD4+ and
CD8+ T (both p < 0.05), and CD38 and HLA-DR. on CD4+ (p < 0.01)
Interpretation: Compared to placebo in clinical and virologic outcomes and improvement of inflammatory out comes, the superiority of NTZ warrants further investigation of this drug for moderate COVID-19 in larger clinical
trials. A higher incidence of adverse events in the placebo arm might be attributed to COVID-19 related symptoms.
Funding: This study was supported by Farmoquimica (FQM), Brazil. Laboratory testing was partially sup ported by a grant from CNPq, Brazil (RD).
Palabras clave en ingles
COVID-19Nitazoxanide
Ensaio clínico controlado randomizado
Marcadores de ativação celular linfócitos
Interleucinas
Palabras clave
COVID-19Nitazoxanide
Randomized controlled clinical trial
Lymphocytes cell activation markers
Interleukins
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